Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 744
- 试验地点
- 1
- 主要终点
- Cumulative incidence of Diabetes Mellitus after randomization
研究概览
简要总结
The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30<Age<71
- •BMI≥23 kg/m2
- •'75g Oral glucose tolerance 2 hours after the test Blood glucose140~199mg/dL' or 'Fasting Blood Sugar 110~125 mg/dL' or 'HbA1c 5.7%~6.4%'
排除标准
- •Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
- •Type 2 Diabetes Mellitus
- •Who diagnosed with Diabetes Mellitus except for maternity period.
- •Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except for maternity period.
- •Fasting Glucose≥ 126 mg/dL
- •75g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL
- •HbA1c ≥ 6.5%
- •Who life expectancy is short.
- •Cardiac history
- •History of severe cardiovascular disease within the last 6 months (cerebral hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.)
- •Systolic blood pressure >180 mmHg or Diastolic blood pressure >105 mmHg
- •aortic stenosis
- •Left bundle branch block or Third degree AV block
- •Who had been diagnosed and treated for malignant tumors including leukemia and lymphoma within the last 5 years
- •Abnormal renal function (Creatinine ≥ 1.4 mg/dL (male) or ≥ 1.3 mg/dL (female) or Urine Protein ≥ 2 +)
- •Anemia(Hematocrit <36%((male) or><33%(female)) ⑤ Cirrhosis or chronic active hepatitis (AST/ALT>３UNL)
- •Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)
- •Who is scheduled major surgery within the last 3 to 6 months or just after the surgery.
- •Chronic infection (HIV, active tuberculosis, etc.)
- •Pulmonary patients who rely on oxygen or daily bronchodilators
- •Who is judged to be able to influence the clinical trial by investigator.
- •Who can not communicate
- •Those with psychiatric or cognitive impairment that may affect the compliance of the clinical trial
- •Those who do not agree to the treatment group allocation by random assignment
- •Those who participate in other studies that may interfere with the clinical trial
- •Those who lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth
- •Those who can not have normal walking or exercise
- •Women who are pregnant
- •Those who are currently pregnant or who are within the last 3 months after giving birth
- •Those planning pregnancy during the clinical trial period
- •Those who have a history of drug and alcohol abuse (acute, chronic) within the last 2 years
- •Those who are not appropriate or unreliable for clinical trials at the discretion of the tester
- •Who taking medication or medical condition that may affect the diagnosis of diabetes
- •Thiazide diuretics
- •Systemic beta blockers
- •Taking Niacin for the treatment of neutropenic depression
- •Possibility of taking or injecting a systemic steroid preparation
- •Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.
- •Taking medicine for weight loss
- •Hormone status is not appropriate during thyroid hormone replacement therapy (TSH abnormal range) (If thyroid hormone therapy is stable for more than 3 months and TSH is normal, the patient can participate in)
- •Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)
- •During treatment, fasting plasma triglyceride> 600 mg / dL
研究组 & 干预措施
Life style modification
Proceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit).
- Exercise: Moderate or abnormal exercise for more than 150 minutes per week (moderate or abnormal exercise for 30 minutes or more per day)
- Diet remedies: Train Calorie intake, nutrient intake and Monitoring.
干预措施: Exercise and Diet remedies (Behavioral)
Metformin
After randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.
干预措施: Metformin (Drug)
结局指标
主要结局
Cumulative incidence of Diabetes Mellitus after randomization
时间窗: 36 months from the baseline
Definition of "incidence of Diabetes Mellitus" * Fasting Glucose ≥126 mg/dL or * 75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or * HbA1c≥6.5%
次要结局
- Change on HbA1c(12, 24, 36 months from the baseline)
- Change on Fasting Glucose(12, 24, 36 months from the baseline)
- Change on HOMA2%S(12, 24, 36 months from the baseline)
- Change on HOMA2%B(12, 24, 36 months from the baseline)
研究者
Jeong-taek Woo
Professor
Kyunghee University Medical Center